The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hitachi Cb Mercuray Dental Cone-beam X-ray System.
| Device ID | K033248 |
| 510k Number | K033248 |
| Device Name: | HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Donald James Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-07 |
| Decision Date | 2003-10-20 |
| Summary: | summary |